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Beartrap, you can be certain that one of the in-licensing deals that Northwest Bio has been negotiating, is with Oncovir for Hiltonol (poly-ICLC). We’ve discussed before about Northwest Bio’s patents and plans for a 10x more potent form of DCVax-L, which is the combination with poly-ICLC. This is the next generation of DCVax that Northwest Bio discussed in the 10k, and other filings.
I think it’s also very likely that another in-licensing deal is with Daiichi Sankyo for Pexidartinib (CSF1R inhibitor). These are the adjuvants that Dr. Liau has trialed at UCLA, which have shown tremendous results. Northwest Bio added Dr. Liau to the Scientific Advisory Board to assist with these registrational trials, and I think they will begin as soon as possible.
What is not very likely however, is that the marketing application that has been submitted to the MHRA includes either of these adjuvants. I’m firmly in the camp that says Northwest Bio will need to first receive approval for DCVax-L as a mono therapy added to the current standard of care. I also don’t believe that Northwest Bio has enough data to seek regulatory approval for the combination with poly-ICLC at this time, but I think it’s certainly in their near-term plans. (They may use the new standard of care, which includes DCVax-L, as the comparator arm)
Really Doc? A thousand patients a month? Could you define the timeframe of “about ready?”
That’s about 33 batches a day. Do you understand what that would require? How many Flaskworks systems, Qualified Persons, etc.?
beartrap, that’s the hard part. When is “close to approval?” I don’t think compassionate-use patients or Northwest Bio will actually know when marketing approval is coming, until the day the decision is made, so it may become increasingly difficult for those patients to decide whether to pay themselves and begin treatment in the coming months, knowing that marketing approval could be coming any day.
I do think the health ministers at the NHS understand the desperate situation that glioblastoma patients would be in, if compassionate use is no longer allowed, when DCVax receives a commercial license, especially if a decision from NICE doesn’t follow rapidly. And I agree that there will certainly be pressure to act on cancer patient’s behalf, if that’s what you meant by being “forced.” It seems reasonable to think that a funding source like the Cancer Drug Fund could be used to help some patients, and this would allow Northwest Bio to cover the manufacturing costs in the interim period between commercial approval, and a NICE reimbursement decision.
When DCVax receives reimbursement, I think they could continue to manufacture using the manual method in a limited capacity until the automated Flaskworks process is approved. Northwest Bio has always put the patients first, so of course they would continue to make the treatment available, but I personally don’t see large scale manual manufacturing initially as you are suggesting could happen with patients flooding in, but who knows.
beartrap, I’ve never seen a treatment that was approved for compassionate use, which later received commercial approval, but I’m unsure if this situation is truly unique. Once DCVax receives commercial approval, I doubt any more patients can be accepted into the Specials program, as it’s only for unlicensed medicines. For patients that were already accepted, they would have already begun treatment and paid for the initial treatment doses. (imagine being that last patient who had to pay for his own treatment, and just discovered that DCVax received commercial approval - ugh!)
I know the NICE assessment process starts earlier so there isn’t as long of an interim waiting period after a drug receives a commercial license, before a reimbursement decision is made, but I think it still could be up to a couple months after commercial approval. The Cancer Drug Fund may cover the cost of some treatments in the interim period until a NICE reimbursement decision is made, but there are limits, so I doubt they could cover everyone if there truly was a rush of patients.
I have reasons to think that the plan has been to start commercial manufacturing with the automated Flaskworks process, even if it occurs a few months after approval, but I’ve admitted that could be wrong, and I’m open to other possibilities. Everyone is certainly free to have a different opinion and believe whatever they wish.
flipper, I don’t think senti was really saying “that marketing approval for DCVax-l is now awaiting Eden approval,” or I wouldn’t have agreed.
I’m also not suggesting that “the NICE reimbursement process is not currently running parallel.”
I’m suggesting that all three timelines are running in parallel. I should rephrase that part about all timelines being independent though, as of course the NICE reimbursement is tied to the marketing approval.
As I’m re-reading this, I’m also not suggesting just about everything else in your response. You’re just putting words in my mouth, so I’ll just leave it there.
meirluc, Northwest Bio has always said they want this treatment available to everyone, not only those that insurance is willing to pay a high price for, so that requires automated manufacturing. Along with the Flaskworks automated manufacturing process, Northwest Bio (Advent) has also been automating final product testing methods (assays), for a completely digital manufacturing and release process that will allow a much more rapid batch verification and final product release. I believe this may be all tied together, so there may not be an interim step to manufacture commercially using the manual method for a few months, and then switch over, and then negotiate a different price based on a different manufacturing method.
As far as the timing of everything, I’m just speculating as I see it, and could be wrong, so we will have to see how it plays out. I do think many investors here don’t fully understand or appreciate how difficult it is for a small company like Northwest Bio to bring a novel cell therapy treatment to market, and be required to pioneer and orchestrate so many moving parts, especially with contractors and backlogged regulators. It’s far easier to sit in the back seat (with a very limited view) and point fingers at the wouldas and couldas along the way. (I’m not saying that you’re doing this meirluc)
I keep hearing this same line repeated - that all these cancer patients are dying because it is taking so long to bring this treatment to market, and somehow, that is seen as Northwest Bio’s fault. Let’s get something straight: The length of time it has taken is not all Northwest Bio’s fault. And neither is all the dilution that resulted from the short attack, and being forced to raise capital at prices well below $1, with warrants and other unfavorable terms attached.
Remember that Northwest Bio was on track with multiple clinical trials for both DCVax-L and Direct, attending investor conferences, trading on the Nasdaq, receiving investment from institutional investors, before it was attacked, frivolous lawsuits brought against them, and a false narrative created and spread, to make to appear as if “DCVax doesn’t work, the phase III trial failed, and management is misleading investors.”
The fact is, that Northwest Bio’s stock had risen rapidly to a high of over $12 which gained the attention of nefarious hedge funds, who saw an opportunity to make some easy, risk-free money. They hired someone to write a false “research report” as a basis for them to perpetrate a short and distort attack on the stock. These hedge funds are the ones responsible for starving Northwest Bio of the necessary resources required to bring DCVax to market in a timely manner, and depriving cancer patients of this treatment.
Linda Powers and Northwest Bio have survived the attack and overcome numerous hurdles in their path to bringing this novel cell therapy to the commercial market. They have almost solved the major bottlenecks that would prevent the large scale manufacturing and mass distribution of this cell therapy, and are now finally on the verge of regulatory approval. I have full confidence that when the time comes for commercial manufacturing, the best choice will be made, whatever that is.
I agree with senti, that the delays in the submission of the marketing application, delayed the timing of the approval of DCVax, which made it months closer to the potential approval of the Flaskworks’ process. I also agree that the wording of the press release seems to back this up, particularly this line:
beartrap, my answers to your questions about the Sawston manufacturing facility:
For starters, the total size of the Sawston facility is 88,345 square feet on two floors.
eagle, I highlighted that the podcast host, Dr. John Fortunato, has an advanced degree in bioethics, and an interest in clinical ethics in neuro oncology, so as an interviewer, he of all people, should be aware of the conflicts of interest and questionable ethics of the doctors that he is interviewing. It would have been a much more credible and interesting interview if he had done his homework on the subject, and brought it up. Right? This is why it may be ironic to some, but it just seems sad to me that he is either ignorant of this, or worse, complicit.
I thought it was obvious that the comment that I made to “get a clue” was meant for him (to be more aware of the ethical issues). But now that I’ve had to explain all this, perhaps it wasn’t so obvious, and I apologize that this wasn’t more clear.
The podcast host’s academic interests include clinical ethics in neuro oncology. Some might call that ironic, but I think it's pathetic. Get a clue man!
A prognostic biomarker that can identify glioblastoma patients who won’t benefit from chemo . . . and the study involved researchers from King's College London and a collaboration of 11 neuro-oncology centres from across the UK. Hmmmm, interesting timing.
Professor Keyoumars Ashkan and Dagmar Ingeborg Turner reunite, three years after making world-wide headlines
Back in 2020, Professor Ashkan and the team woke violinist Dagmar Ingeborg Turner during the operation to play the violin, acting as a guide to ensure no damage was caused to the crucial areas of the brain that controlled her delicate hand movements.
Prof Ashkan explained: “Dagmar had expressed it was vital that we preserve her ability to play the violin, and as doctors we’re always wanting to advance science to improve the quality of our patients’ lives. “I am truly honoured, and grateful to Dagmar, to have had the opportunity to perform surgery in this way.”
The pair reunited as they visited their appearance in a new exhibition at London’s Hunterian Museum on the power of surgery; Transforming Lives.
https://www.kch.nhs.uk/news/kings-consultant-neurosurgeon-and-patient-reminisce-on-using-the-violin-to-help-surgery/
There are further expansion plans for Sawston, (which may be occurring now) but it appears that Northwest Bio/Advent are being rather secretive about not only these expansion plans, but even the most recent phase II expansion as well. In regulatory filings, all that has been disclosed was that phase II was completed in the 2nd quarter last year, but not the number or type of cleanrooms, or their footprint.
I was hoping to glean some information about this expansion from Catapult’s Cell and Gene Therapy Manufacturing Report last year, but apparently Advent did not provide that information for the 2023 survey, so the report just used previous data for Advent. In footnotes it says, “*** 2022 footprint data has been used,” and still only shows 7 cleanrooms at Sawston. With regard to future capacity and expansion plans, it simply stated:
A potential leukapheresis bottleneck is real, but not right now as Doc implies. It’s a significant business opportunity that will very likely be addressed by the industry when it’s necessary, so it’s really a non-issue in my opinion, but something to be aware of. Lykiri (inadvertently) brought the issue to the board’s attention last year.
Chiu, I dunno about a “$10/share” value today, but maybe fairly soon. I think similar cell therapy companies like Kite and Juno, that were pre-revenue and pre-approval, had market caps of four or five billion before their buyouts, which is probably a reasonable value for Northwest Bio at this time. I think NWBO would probably be closer to that valuation if the stock had institutional investors and was trading on a national exchange, and not being manipulated on the OTC. The reason those companies were valued at $10-12B is because they were acquired at a premium; a price that also valued their future revenues. I think I’ve posted this before, but there’s an interesting article about Gilead’s acquisition of Kite and how that buyout price was achieved here.
There are many ways to value companies, and I think comparisons to similar companies is a fair method, however, I agree that the comparison of Kite to Northwest Bio begins to fall apart when considering the size of their respective markets, and their ability to capture it, which is why Kite’s buyout price is only a good starting point for Northwest Bio’s future value. It took Kite nearly 6 years to achieve $1.5B in annual sales. Northwest Bio’s future revenues are likely to be considerably higher than Kite’s, not only due to a much larger market, no competition, and DCVax’s ability to safely combine with many other agents, but also because Flaskworks’ automated manufacturing will allow much faster growth.
I think your argument here is solid, but it’s probably not enough to counter the continual manipulation of the stock as you suggest. Unfortunately, true demand for the stock is capped on the OTC since there are only retail buyers, and the price can be controlled with as little as a few million in capital. It seems that Northwest Bio understands and this, and doesn’t seem particularly concerned right now about the stock price or countering the false narratives like they used to, (except with the medical and scientific communities) while the stock trades on the OTC. I think this is all going to change in the near future though.
I think regulatory approval is the lynchpin which enables other events to occur, similar to the JAMA journal article finally providing validation of the science and trial (which allowed the lawsuit to be filed against the manipulators). Approval by the MHRA will provide further legitimacy of the science, and de-risk the company for critical investment by large investors and potentially a partner(s). And we know that Linda Powers has plans to list the company on a national exchange which will attract institutional investment, analyst coverage, publicity, and Northwest Bio will finally gain the value, and exposure that the science and company deserves.
In hindsight, knowing now that the MHRA’s processing of clinical trial applications was so backlogged, and yet during this period, Northwest Bio was somehow able to to receive a surprisingly speedy approval for the pediatric trial, (a process which normally takes a year even without backlogs) it seems far more impressive. I think this bodes well for the current marketing application timeline.
To say that Merck’s shelf registration is connected to Northwest Bio is a bit of a stretch, but I can’t deny that it would be necessary. And you either didn’t look very hard, or maybe didn’t know what to look for. (newman sure doesn’t)
https://d18rn0p25nwr6d.cloudfront.net/CIK-0000064978/ff0e430e-39e6-42c8-aeb4-9a8c1b7d4b92.pdf
ilovetech, I’m not sure how closely you've been paying attention to the defendant’s posture and bullying tactics, but everything that I’ve seen from the defendants thus far, leads me to believe that they will play this out, and are not in any hurry to settle.
flipper, I think many of us (including management) have long suspected that some of the parties involved with financings over the years were at least partially involved in the manipulation of the stock. It won’t be known who all the responsible entities are, and whether there was any coordination among them until discovery, and even then, it may be difficult to get the whole story, as there will be attempts to disguise their nefarious activities and obfuscation of facts. Northwest Bio has their own record of the relevant financing dates to pin some of it down though.
Other than the reputational damage, loss of institutional investors, analyst coverage, and illiquidity of the stock, another major ramification of de-listing from a national exchange is the reduction in access to capital, both terms of the equity and loans, but also the quality of the lenders. It’s pretty well known that there are a number of shady lenders who prey on small companies on the OTC.
Anyone who has watched, or traded in NWBO, has probably seen some odd trading, and has also seen the price fall right before the close with unusual regularity. It’s probably unlikely that it’s being monitored though, as authorities are stretched thin, and there’s much less oversight on the OTC.
Laura Posner is very well aware of certain stock manipulation techniques that may be familiar to us, and we seem to witness in NWBO, like “spoofing and layering,” and “banging the close.” Perhaps exposing trading records and other information will shed some light on this for authorities, and potentially even exposing “inadvertent” mislabeling of trades, or algorithmic collusion, and other less obvious nefarious activities, so it will become too difficult for them to “turn a blind eye.”
Exactly, minimize financial exposure. This has probably been in the works for a while . . .
#AMC and #Gamestop investors remember this;
— The Butcher of Wall Street Marcel Kalinovic (@BossBlunts1) December 1, 2023
Credit Suisse didn't report ANY short positions from February 2015 through April 2022.
More than 7 years‼️
Now #UBS is stuck with the legacy costs from both #CS and #Archegos.#Blackstone is closing a fund that offers investors… pic.twitter.com/cFP9Frf5cT
ski, I think there are still many unanswered questions about DCVax. I know that all of us are hopeful that the budgetary constraints that have burdened this company will be over soon, and they will finally begin more clinical trials to get some of those answers.
This reminded me that I sent a note about this study on brain tumors and circadian rhythms to Dr. Liau a few years ago, (I didn’t have access) and she replied that she was interested.
Thanks Lykiri, interesting indeed. He’s courageous, and I wish him the best. Count me in.
I wouldn’t worry GermanCol, you still have cred. Most of us here have highly developed FUD detectors, and can determine fairly quickly who are the sincere, credible posters. I think you’ve established your credibility and distinguished yourself from the usual suspects. Flipper doesn’t speak for everyone, and he sometimes mischaracterizes people. I remember he labeled me a pumper and a day trader because I mistakenly thought the Flaskworks development work was further along than it actually was. Carry on.
ATLnsider, I don’t pay much attention to all the negative noise makers on this board. I agree with your point that even at $250K, DCVax is relatively inexpensive compared to all of those other cell and gene therapy treatments you illustrated. And by stretching payments, it lowers the annual cost to governments to a much more manageable level.
Your Casgevy example demonstrates exactly what I was saying; governments are simply not able to cover all eligible patients for all of these therapies, so they are forced to limit the number of patients they will cover. I think we agree that in order to continue to receive insurance coverage as the patient numbers grow, Northwest Bio will have to keep prices at manageable levels for government budgets, so bringing and keeping production costs down, will be critical to scaling DCVax beyond GBM.
ATLnsider, it was just a minor point, so I didn’t really explain it properly. I agree that in some cases, depending on the size of the tumor, enough tissue can be saved to potentially produce 20 or more doses. And Dr. Bosch’s compassionate-use case from that presentation is a perfect example of that. (I had forgotten about that patient, Sarah, so thanks for the reminder of just how impressively DCVax works).
I was just saying that this number of doses is really the exception, and not the rule. So I think assuming stretching payments over 8 to 10 years for everyone, as you posited in one of your pricing assumptions, may be a bit of a reach, but the other possibility of stretching payments over 3 years seems more reasonable to me. And although Sarah had her doses frozen for 7 years, I think the regulators would need a documented stability study to confirm viability for eight or ten years for the commercial product.
Some excellent points ATLnsider, and I’m quite certain that NICE and Northwest Bio will negotiate an acceptable pricing model, (likely spreading payments over years) and DCVax will be covered by the NHS. No doubt about this.
A couple minor points of difference; studies have confirmed product stability for 3 years, or ~10 doses per batch. This will be extended obviously for another 3 years, if a new batch is made for a recurrent patient. Also on your second point, I personally don’t think patients are used for the Flaskworks development work. I thought they could have gone that route years ago, if they requested approval for the Flaskworks process for investigational use, but they didn’t. I think they are probably using a commercially available blood product like Leukopaks, for the comparability studies. Although these products are from healthy volunteers, it’s acceptable to regulators, as long as it’s used for both sides of the comparison.
The ATMP Pricing is really great information, and I hadn’t seen all that in one document. If you notice though, all these ATMP’s are for rare conditions, so the patient number are not large, which is a very big consideration for these countries with national insurance coverage. When you start talking about patient numbers in the tens of thousands per year or more, it could be a real budget breaker. With just the DCVax pricing numbers discussed, in the UK for example, at 3K GBM patients per year, that is close to $750M for that one product alone, and doesn’t even consider the other treatment therapies. (removing Temo will help)
This is why it’s necessary to bring the cost of production down as low as possible, in order to have the lowest price, or the coverage will be limited. I’ve thought that Northwest Bio may bring manufacturing in house (i.e. buy Advent) at some point, to lower the cost of production even further, possibly when automated commercial production begins, or when production numbers reach the point of limiting coverage. This way, the profit that Advent would have charged, could be passed along as cost savings to governments, in order to keep the number of patients covered, as high as possible.
Thanks for sharing this brutal truth smokey. I join everyone here in wishing you the strength to beat this cancer. It’s truly unfortunate that most cancer patients must still endure this poisoning to rid the cancer.
When you see what goes on in the stock market and pharmaceutical industry to put profits over quality of care, and stifle innovation and change, it’s no wonder the standard of care has barely improved in decades. I know we aren’t alone in hoping that Northwest Bio, and next-generation immunotherapies like DCVax, can improve this.
Stay strong, have hope, and never give up!
BS exwannabe. It’s a comparability study, so clinical trials are NOT necessary. You can keep repeating lies, but it doesn’t make them true.
Advent has already proven the Flaskworks systems can produce a comparable product. And guess what? They did it without a clinical trial:
That was one of the more interesting nuggets in the 10-K. I’m certainly not alone in thinking that Dr. Liau and Northwest Bio would like to trial DCVax without the toxic chemotherapy temozolomide (Temodar) handicapping DCVax by damaging and depleting the patient’s immune system, prior to using an immunotherapy, that requires the patient’s own immune system to kill the cancer. Right? This seems like common sense even to us non-oncologists, to support and boost the immune system first, to help optimize and maximize the effect of DCVax and poly-ICLC, and potentially improve the already impressive survival numbers even more.
This case study appears to be a recurrent “Specials” patient, who had another batch made, which may form the basis for excluding chemo in newly diagnosed patients, since DCVax works without Temo in these recurrent cases. And I doubt that it would be difficult to get the patient’s consent for this, particularly once they understand how chemo and immunotherapy work.
If true, this exclusion will be seen as a threat to Merck’s chemo business, but it may be balanced by good news for their immunotherapy business if Keytruda becomes part of the standard treatment option in combination with DCVax and poly-ICLC, in the cases where the cancer eventually returns. I think the incidence of rGBM will probably decline after DCVax becomes part of the front-line treatment though. Either way, as this becomes more clear, it seems likely that Northwest Bio will have Merck’s interest.
Sore subject, but yes ipilimumab (Yervoy) was developed by Medarex, which first partnered with Bristol Myers, and then was acquired by Bristol Myers for a measly $2.4B. In my opinion, it was one of the biggest biotech ripoffs in modern history. (fortunately, Linda Powers wouldn’t let this happen to Northwest Bio)
I owned Medarex, and I was against the buyout. When news of ipilimumab’s ability to shrink tumors came out, the stock price reached $17 a share, but it fell back to about $9, when Bristol offered to buy it for around $16. In the buyout, Bristol Myers acquired Medarex’s UltiMAb Human Antibody Development System, which had 6 or 7 antibodies for immunology and oncology (including eventual blockbusters Opdivo, and Yervoy) in clinical trials, a next-generation antibody-drug conjugate technology, plus royalties on sales of Stelara, Ilaris, and Simponi.
This article paints a picture of a “fruitful” and “transformative” partnership turned acquisition (which I would not) in case you’re interested:
Bristol/Medarex: A Transformational Acquisition Rooted In Collaboration
18 Sep 2017 Joseph Haas
https://invivo.citeline.com/IV005175/BristolMedarex-A-Transformational-Acquisition-Rooted-In-Collaboration
Good article, but not DCVax. First clue was:
100% senti. It’s more than just “a small little biotech company, the small little biotech company that could” (love that line) taking on the titans of Wall Street. There are much larger implications of Northwest Bio’s lawsuit for the market, other companies, and the Department of Justice, to name a few. It could get very interesting . . .
The Financial Times article on Northwest Bio’s lawsuit against the market makers here, apparently generated quite a bit of interest, so the author, Joe Miller discusses the “bombshell lawsuit,” spoofing, and high frequency trading practices on the "Unhedged" podcast.
Inside the traders’ black box
A lawsuit against market makers may reveal how high-frequency trades really work
Ethan Wu speaks to FT legal correspondent Joe Miller
Market watchers have wondered for years about what really goes on inside trading firms like Citadel Securities, Susquehanna and Virtu. A recent ruling in a lawsuit brought by a medical company may provide some answers. Today on the show, host Ethan Wu asks FT reporter Joe Miller about the case, brought by Northwest Biotherapeutics.
https://www.ft.com/content/677b2015-fddf-4538-acf1-d27b18976ec6
Here’s the transcript:
Inside the traders’ black box
https://www.ft.com/content/2ed91dc8-5e13-4dba-a9bb-5004a31e671c
Astavakra, I don’t think the MHRA’s information sharing affects NICE’s assessment decision one way or the other. It merely informs them that the marketing application has been filed so they can begin planning for it, and scheduling assessors and meetings etc., rather than waiting until the applicant contacts them to begin their assessment preparations.
Historically, NICE’s assessment did not begin until after the MHRA market authorization approval decision, so coverage did not begin until many months (6+) later. After Brexit, they attempted to begin the assessment earlier, during the MHRA assessment process, so coverage would occur simultaneously with marketing approval. Unfortunately, their timelines have also been backed up, and this hasn’t really happened. So this guidance is intended to make a meaningful time-saving improvement, which could speed the process, and help to make the coverage available sooner, if not simultaneous.
I think an update (not a decision) from NICE is expected sometime soon, so I doubt it would be considered major news. I personally have no doubt that NICE will cover DCVax, since they have previously covered the CAR-T treatments, which are almost double the price, and had zero long-term data available during their initial assessment. The question I’ve had is: how long will the assessment and price negotiations take? This guidance seems to suggest that the NICE decision may not be that long after marketing approval.
The MHRA shares the marketing applicant’s information with their health system partners now, to speed access to newly authorized treatments:
Right, there's an important distinction between a request for information DURING the first phase of assessment when the assessors are requesting clarification or information from clinical trial sites etc., (as Northwest Bio stated they would in their PR) and a request for information AFTER the initial assessment phase has been completed. If there is still clarification or information needed at that point after the initial assessment, then the assessment clock stops, until the information is provided. This will obviously add time to the length of the total assessment beyond the 150 days, while the information requested during the initial assessment will not.